Pharmaceutical composition of repaglinide and metformin hydrochloride and preparation technology of pharmaceutical composition

A technology of metformin hydrochloride and metformin, which is applied in the directions of drug combinations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of difficulty in releasing drugs, affecting drug release, and high equipment requirements, and achieving dissolution The effect of consistent curve, product safety and stable particle content

Active Publication Date: 2016-05-04
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The above-mentioned double-layer sustained-release tablets or separately compressed small tablets have high requirements on equipment and are difficult to industrialize, and the preparation process of the double-layer sustained-release tablets will cause the tablet hardness to be too large, which will affect the drug release, and the connection surface of the upper and lower double-layer tablets is difficult to release. drug
[0006] During the compatibility study of repaglinide and metformin hydrochloride, it was found that the compatibility of the two was poor under high temperature conditions

Method used

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  • Pharmaceutical composition of repaglinide and metformin hydrochloride and preparation technology of pharmaceutical composition
  • Pharmaceutical composition of repaglinide and metformin hydrochloride and preparation technology of pharmaceutical composition
  • Pharmaceutical composition of repaglinide and metformin hydrochloride and preparation technology of pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Partial prescription of repaglinide:

[0052]

[0053] Take the material according to the above prescription, mix the active substance, sodium lauryl sulfate and meglumine evenly and pulverize it, then mix it with microcrystalline cellulose and perform dry granulation, then add magnesium stearate and mix to obtain the final mixture .

[0054] The A-D production process is smooth and the product quality is good. The particle results are shown in Table 1 below.

[0055] Table 1 Example 1 experiment related results

[0056]

[0057] Note: The particle content in this article refers to the measured value / theoretical value of the weight percentage of API in the composition in this field. The theoretical value is also called the labeled amount, and it is usually based on the proportion of API in the formulation design.

[0058] It can be seen from the above data that sodium lauryl sulfate can also act as a lubricant during the dry granulation process, and the prepare...

Embodiment 2

[0061]

[0062] Preparation Process:

[0063] Option A

[0064] Part of repaglinide: Mix repaglinide, microcrystalline cellulose, meglumine, and sodium lauryl sulfate evenly, then mix with magnesium stearate, and then carry out dry granulation, and the granules obtained by granulation Diameter 100μm ~ 400μm.

[0065]Metformin hydrochloride part: Metformin hydrochloride and microcrystalline cellulose are evenly mixed, granulated with povidone aqueous solution, and the obtained granules are dried and sized.

[0066] Blending: mix repaglinide granules, metformin hydrochloride granules, and crospovidone granules according to the prescription quantity, then mix with magnesium stearate, and compress into tablets.

[0067] Option B

[0068] Part of repaglinide: Mix repaglinide, microcrystalline cellulose, meglumine, and sodium lauryl sulfate evenly, granulate with purified water, dry, and granulate.

[0069] Metformin hydrochloride part: Metformin hydrochloride and microcrysta...

Embodiment 3

[0082]

[0083] Preparation Process:

[0084] Part of repaglinide: Mix repaglinide, microcrystalline cellulose, meglumine, and sodium lauryl sulfate evenly, then mix with magnesium stearate, and then carry out dry granulation, and the granules obtained by granulation Diameter 100μm ~ 400μm.

[0085] Metformin hydrochloride part: Metformin hydrochloride and microcrystalline cellulose are evenly mixed, granulated with povidone aqueous solution, and the obtained granules are dried and sized.

[0086] Blending: mix repaglinide granules, metformin hydrochloride granules, and crospovidone granules according to the prescription quantity, then mix with magnesium stearate, and compress into tablets.

[0087] Table 4 Dissolution data of repaglinide

[0088]

[0089] Table 5 Metformin Hydrochloride Dissolution Data

[0090]

[0091] It can be seen from the above data that the two active substances can achieve rapid dissolution in different dissolution media, and the dissoluti...

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Abstract

The invention relates to the field of pharmaceutic preparation and in particular relates to a pharmaceutical composition of repaglinide and metformin hydrochloride and a preparation technology of the pharmaceutical composition. The technology comprises the steps of performing dry granulating on repaglinide, performing wet granulation on metformin hydrochloride, then mixing two kinds of particulate matters, and tabletting, so as to solve the problem of compatibility of the repaglinide and the metformin hydrochloride, wherein repaglinide particles take microcrystalline cellulose as a filling agent and a disintegrating agent, meglumine as an alkaline agent, lauryl sodium sulfate as a solubilizing agent, and magnesium stearate as a lubricating agent. The preparation is quick in compound content dissolution, and the dissolution of the repaglinide and the dissolution of the metformin hydrochloride are consistent, and are stable in various dissolution media; related substances of a product are less, the stability and quality are controllable, and the safety of the medicine is guaranteed.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to repaglinide and metformin hydrochloride solid preparations with excellent storage stability and a preparation method thereof. Background technique [0002] Repaglinide, as shown in formula (I), is S(+)-2-ethoxy-4-{2-[(3-methyl-1(2-(1-piperidinyl)phenyl) Butyl)amino]-2-oxoethyl}benzoic acid. Repaglinide Metformin Tablets are used to assist diet and exercise improvement. Those who have received repaglinide and metformin hydrochloride treatment, or who have received meglitinide monotherapy and metformin hydrochloride monotherapy cannot adequately control blood sugar Glycemic control in adults with type 2 diabetes. [0003] [0004] Due to the low solubility of repaglinide in water, only 0.005mg / mL, and metformin hydrochloride is a water-soluble drug, the use of conventional technology for tablet compression will result in that repaglinide will not be released if the r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/451A61K47/20A61P3/10A61K31/155
CPCA61K9/2013A61K9/2086A61K31/155A61K31/451A61K2300/00
Inventor 拥青她姆陈中亚周炳城
Owner JIANGSU HANSOH PHARMA CO LTD
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